Investigation of Vascular Relaxing Effects of Candesartan and Pioglitazone. - Full Text View

Sponsor:	Dresden University of Technology
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00154037

Purpose

The study is designed to test the hypothesis in healthy subjects that candesartan and pioglitazone provide additional vascular relaxing or modulating effects in addition to their blood-pressure and blood glucose level reducing ability, respectively.

Condition	Intervention
Healthy Subjects	Drug: Pioglitazone (drug) and/or candesartan (drug)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Characterization of Vascular Effects of Candesartan and Pioglitazone.

Resource links provided by NLM:

Drug Information available for: Pioglitazone Pioglitazone hydrochloride CV 11974 Candesartan cilexetil

U.S. FDA Resources

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:

Vascular reactivity

Secondary Outcome Measures:

Pulse wave velocity
Changes in Angiotensin metabolites

Estimated Enrollment:	40
Study Start Date:	October 2005
Estimated Study Completion Date:	September 2006

Detailed Description:

The aim of the study is to investigate the effect of oral candesartan and/ or rosiglitazone therapy on the vascular responsiveness of different vasoactive compounds (angiotensin II, insulin, histamine and glyceroltrinitrate) in healthy subjects. Pioglitazone will be given orally (4 weeks 30mg/d, titrated to 45 mg/d for another 4 weeks). Candesartan will be given orally (4 weeks 8mg/d, titrated to 16 mg/d for another 4 weeks) as treatment. Every subject will receive intravenous stimulation with phenylephrine, angiotensin II, histamine, insulin and glyceroltrinitrate before and after an 8 weeks treatment interval with study medication or placebo. In addition, pulse wave velocity will me measured non-invasively before and after treatment.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male
healthy
18 - 40 years old
non-smoker
no additional medication

Exclusion Criteria:

any relevant disease
smokers
elevated liver enzymes
body weight different from Broca Norm > 20%
allergies

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00154037

Locations

Germany
Institute of Clinical Pharmacology, Medical Faculty, University of Technology
Dresden, Germany, 01307

Sponsors and Collaborators

Dresden University of Technology

Investigators

Study Chair:

Wilhelm Kirch, MD

Institute of Clinical Pharmacology

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00154037 History of Changes
Other Study ID Numbers:	IKPD 02-05
Study First Received:	September 8, 2005
Last Updated:	September 12, 2006
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:

vascular reactivity
venodilation
pulse wave velocity

Additional relevant MeSH terms:

Pioglitazone
Candesartan
Candesartan cilexetil
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012